Uterine hemorrhage controlling system and method

ABSTRACT

An embodiment of a uterine hemorrhage controlling system comprises a suction module including a suction end coupleable to a pump by a connecting tube, and a sealing module coupled to the suction module. The system may further comprise the pump and a filter coupled to the suction module. A uterine hemorrhage controlling method comprises: shielding a suction module that has been delivered into a uterus; sealing an entrance into the uterus while the suction module is situated within the uterus; applying a negative pressure within the uterus upon activation of a pump; and maintaining the negative pressure within the uterus to induce uterine contraction. The method may further comprise delivering the suction module into the uterus; transmitting bodily fluids, out of the uterus through the suction module, and filtering the bodily fluids.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/035,543, filed Jul. 13, 2018, which is a continuation of U.S. patentapplication Ser. No. 13/827,579, filed Mar. 14, 2013, now U.S. Pat. No.10,064,651, which is a continuation-in-part of U.S. patent applicationSer. No. 13/420,871, filed Mar. 15, 2012, now U.S. Pat. No. 9,550,014,each of which are incorporated herein by reference in their entiretiesfor all purposes.

TECHNICAL FIELD

This invention relates generally to the medical device field, and morespecifically to an improved uterine hemorrhage controlling system andmethod.

BACKGROUND

Postpartum hemorrhage, defined as excessive blood loss after birth, isthe leading cause of maternal death in the world, claiming the lives ofover 125,000 mothers every year. Inability to control postpartumbleeding can require a woman to receive multiple blood transfusions, andin severe cases, a full hysterectomy. Accordingly, it is desirable tocontrol such postpartum bleeding, if possible, at its onset. The causeof postpartum hemorrhage, in approximately 80% of cases, is uterineatony, which is the inability of the woman's uterus to contract afterdelivering the child. Risk factors for uterine atony include prolongedstage of labor, preeclamsia, and multiparity.

Postpartum hemorrhage has been traditionally treated using oxytoxicagents, hormonal agents that induce muscle contraction. Unfortunately,studies have increasingly shown that oxytoxic agents do notsignificantly reduce either the incidence of postpartum hemorrhage orthe amount of blood lost. Some studies have even indicated that oxytoxicagents are being overused to the point that this treatment increases therisk of uterine atony. Current medical devices and surgical procedureshave also proven inadequate in reducing postpartum hemorrhage or theamount of blood lost, and/or are extremely invasive.

It has recently been discovered by the inventors that providing negativepressure within the uterus, in combination with sealing an opening tothe uterus or vagina at the distal end, can rapidly induce uterinecontraction to counteract uterine atony, thus reducing or entirelystopping uterine hemorrhaging. Providing negative pressure mayfurthermore be performed in a non-invasive (i.e., non-surgical) manner,effectively removing an inadequacy of other hemorrhage-controllingoptions. With the knowledge of this discovery, the inventors havecreated an improved uterine hemorrhage controlling system and method.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts an embodiment of a uterine hemorrhage controlling system;

FIGS. 2A-2C depict variations of a suction tube and shield of anembodiment of a uterine hemorrhage controlling system;

FIG. 3A depicts a specific example of a uterine hemorrhage controllingsystem;

FIGS. 3B and 3C depict cross-sectional views of suction tube connectingjoints;

FIG. 3D shows an example of a suction tube cross section and opening;

FIGS. 4A and 4B depict examples of suction tubes that also function asshields;

FIG. 4C depicts an example of a system that combines variations ofelements;

FIGS. 5A-5B depict examples of an inflatable sealing module element;

FIGS. 6 and 7 depict examples of sealing module variations;

FIGS. 8A and 8B depict examples of system elements with dualfunctionality;

FIG. 9 depicts an embodiment of steps of a uterine hemorrhagecontrolling method;

FIGS. 10-11 depict embodiments of steps of a uterine hemorrhagecontrolling method; and

FIG. 12 is a schematic showing an implementation of an embodiment of auterine hemorrhage controlling method.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of preferred embodiments of the invention isnot intended to limit the invention to these preferred embodiments, butrather to enable any person skilled in the art to make and use thisinvention.

1. System

As shown in FIG. 1, an embodiment of a uterine hemorrhage controllingsystem 100 comprises a suction module 110 including a suction end 120coupleable to a pump 130 by a connecting tube 126, and a sealing module140 coupled to the suction module 110. The system 100 may furthercomprise the pump 130 and a filter 150 coupled to the suction module110. At least a portion of the system 100 is preferably deliveredtransvaginally, and facilitates contraction of the uterus to counteractuterine atony. Thus, the system 100 functions to reduce or entirely stoputerine hemorrhaging, in order to substantially reduce total blood lostfrom the uterus after childbirth. The system 100 may further function toreduce other issues associated with childbirth, including a need for ablood transfusion or a hysterectomy.

1.1 System—Suction Module

The suction module 110 comprises a suction end 120 coupleable to a pump130 by a connecting tube 126, and functions to provide negative pressurewithin the uterus to facilitate uterine contraction. Preferably,negative pressure provided by the suction module 110 results in auniform mechanical stimulus to the uterine wall, in order to facilitatesubstantially even contractile movement of tissue; however, the suctionmodule 110 may alternatively be configured to provide a non-uniformmechanical stimulus to the uterine wall, or to decrease intra-uterinepressure and/or volume by any suitable method (e.g., mechanically,chemically, creation of a vacuum, reduction in intrauterinetemperature). The suction module 110 preferably comprises a distal end112 and a proximal end 113, as shown in FIG. 1, wherein the distal end112 comprises the suction end 120 and is configured to enter the uterus,and the proximal end 113 comprises the pump 130 and is configured toremain external to the uterus. However, both the distal end 112 and theproximal end 113 may be configured to enter the uterus. Preferably, thedistal end 112 and the proximal end 113 are coupled by the connectingtube 126 (e.g., by a conduit, tubing, chamber), and may be furtherconfigured to be reversibly coupled in variations wherein at least oneof the distal end 112 and the proximal end 113 is configured to bedisposable. In some variations, the suction module 110 may furthercomprise a pressure sensor and/or a controller, which functions tofacilitate measurement of a pressure provided by the pump 130 and/or apressure within the uterus, and also to controllably adjust a negativepressure provided within the uterus.

The suction end 120 is configured to be transvaginally delivered, andfunctions to transmit a negative pressure provided by the pump 130 tothe interior of the uterus, while preventing tissue or any othersubstance within the uterus from obstructing the suction end 120. Thesuction end 120 is preferably flexible, and may be further configured tobe deformed into one or more configurations. Flexibility in the suctionend 120 may further function to facilitate conformation of the suctionend 120 to the intra-uterine anatomy of the patient. Variations of aflexible suction end 120 may be configured to be reversibly orirreversibly deformable. Alternatively, the suction end 120 may be rigidand substantially non-deformable, or may be configured to be rigid inone environment, and transition to a flexible state in anotherenvironment. Preferably, the suction end 120 is composed or partiallycomposed of a medical-grade material (e.g., polyethylene, polypropylene,stainless steel, cobalt chrome, ceramic), such that the suction end 120does not induce an adverse reaction after being inserted into a uterusof the patient. The suction end 120 may further be configured to preventor counteract an inflammatory or biorejection response by processing thesuction end material with anti-inflammatory and/or anti-biorejectionagents (e.g., steroidal or non-steroidal anti-inflammatory agents).However, the suction end 120 may alternatively be composed of anysuitable material that does not prevent the suction end 120 fromtransmitting a negative pressure to the interior of the uterus.

Preferably, at least a portion of the suction end 120 is configured tobe disposable, such that the suction module 110 is modular and comprisescomponents that may be removably attached together. In variations of amodular suction module 110, attachment locations between variouscomponents are preferably configured to provide hermetic seals, in orderto prevent fluid and/or air leakage along the suction module 110. Atleast a portion of the suction end 120 may alternatively be configuredto be reusable, and may or may not comprise hermetic seals at locationsof coupling. In variations wherein a portion of the suction end 120 isconfigured to be reusable, the suction end 120 preferably comprises amaterial that may be sterilized without compromising the function of thesuction end 120. The material may be configured to be sterilized by dryheat sterilization, moist heat sterilization, ethylene oxidesterilization, radiation (e.g., ultraviolet, gamma, electron beam),liquid chemical sterilization, or any other suitable sterilizationmethod. In a specific example, the material is configured to besterilized according to the U.S. Food and Drug Administration 510(k)Sterility Review Guidance K90-1.

The suction end 120 of the preferred embodiments includes a suction tube122 and a shield 127 coupled to a distal portion of the suction tube 122configured to enter the uterus. The suction end 120 may, however, omitthe shield 127 in other embodiments. The suction tube 122 comprises anopening 123 fluidically coupled to a lumen of the connecting tube 126,which functions to allow a negative pressure to be transmitted from thepump 130, through the connecting tube 126, to the uterus. Preferably,the suction tube 122 is flexible, as described above; however, thesuction tube 122 may alternatively be non-flexible or undergo atransition from a flexible state to a rigid state in differentenvironments. Additionally, the suction tube 122 may be one of a set ofsuction tubes 124 coupled to the pump 130, such that the suction end 120has an inherent redundancy of suction tubes configured to allow anegative pressure to be transmitted into the uterus. Furthermore, thesuction tube(s) may comprise a set of openings 125, the suction tube(s)may be configured to have a curved portion, and/or the suction tube(s)may be configured to have a non-curved portion. Additionally, thesuction tube(s) 122 may have any suitable length, diameter, orcross-sectional shape (e.g., uniform, non-uniform) configured tofacilitate provision of a negative pressure within the uterus.

In a first variation, the suction end 120 comprises a single suctiontube 122 with a single opening 123. In an example of the firstvariation, a lumen of the single suction tube 122 terminates in thesingle opening 123 at a distal end of the suction tube 122, and inanother example of the first variation, the single opening 123 islocated at any point along the length of the suction tube 122. In asecond variation, the suction end 120 comprises a single suction tube122 with a set of openings 125. In a third variation, the suction end120 comprises a set of suction tubes 124 with a set of openings 125. Inother variations, the suction end 120 may have any suitable combinationof the above variations, or any suitable configuration to facilitateprovision of a negative pressure within the uterus.

The shield 127 functions to provide a barrier, in order to preventobstruction of the opening(s) of the suction tube 122 or set of suctiontubes 124 by uterine tissue or any other substance within the uterus.The shield 127 is preferably coupled to a distal portion of the suctiontube 122 or set of suction tubes 124 configured to enter the uterus, butmay be coupled to any suitable portion of the suction module 110 orsuction tube 122 to prevent obstruction. The shield 127 is preferablycomposed of a medical-grade material, such as a medical-grade metal orpolymer, but may be composed of any suitable material to preventobstruction of the opening(s). Additionally, the shield 127 may be rigidor flexible.

In a first variation, the shield 127′ is configured to couple to aportion of a suction tube 122 and diverge outward from the suction tube122 at least at a location of an opening 123 to form a perimeter, suchthat uterine tissue or other tissue is prevented from impinging upon theopening 123. In an example of the first variation, the shield 127′comprises a conical or pyramidal surface 128′ that flanks a suction tube122 and that has an open mouth 129′ that extends beyond a distal end ofthe suction tube 122, as shown in FIG. 2A. In a second variation, theshield 127″ may partially encapsulate an opening 123 (e.g., by a cage ora frame) to prevent obstruction of the opening 123. In an example of thesecond variation, as shown in FIG. 2B, the shield 127″ may form abulbous cage 199″ about an opening 123. The dimensions of the bulbouscage are preferably smaller than the atonic uterus, such that sufficientcontraction may be enabled, and smaller than the vagina opening, suchthat correct position may be reached. In another example of the secondvariation, as shown in FIG. 2C, the shield 127″ may form a capsule 198″about an opening, wherein the body of the capsule 198″ preventsobstruction of an opening 123 of the suction tube 122, and wherein thecapsule has an hole 197″ configured to allow the suction tube 122 tofacilitate creating of a negative pressure within the uterus. The shield127 may, however, comprise any suitable geometry and/or configuration toprevent obstruction of the opening(s) of the suction tube 122 or set ofsuction tubes 124.

In alternative variations, the suction tube 122 or the set of suctiontubes 124 may be configured to also function as a shield 127 (or to bephysically coextensive with the shield). In these alternativevariations, the suction tube 122 or the set of suction tubes 124 thusfunctions to simultaneously allow a negative pressure to be appliedwithin the uterus, while preventing obstruction of suction tubeopening(s). This dual-functionality may be enabled by strategicplacement of the opening(s) 123, 125 of the suction tube(s) 122, 124,and/or by geometrically configuring the suction tube(s) to preventobstruction of an opening or openings.

In a first variation of an embodiment wherein the suction tube(s)function as a shield, the suction end 120′ may comprise a set of curvedsuction tubes 124′ connected to a connecting tube 126 coupleable to thepump 130, as shown in FIG. 3A. In an example of the first variation, theset of curved suction tubes 124′ may comprise a first suction tube 161and a second suction tube 162 that are arranged in loops that extenddifferent distances. As shown in the cross sections of FIGS. 3B and 3C,the first suction tube 161 and the second suction tube 162 may becoupled to the connecting tube 126 by a joint 164. In the example, thefirst suction tube 161 may have a longer length and extend in a widerloop from the distal end 112 of the suction module, and the secondsuction tube 162 may have a shorter length and be configured in a loopthat is within the loop created by the first suction tube 161. The firstsuction tube 161 and the second suction tube 162 in the example may haveidentical or non-identical cross sections (e.g., dimensions, geometry,lumen configurations), a maximum cross sectional dimension between 25 mmand 125 mm, and substantially smooth surfaces to prevent abrasion withinthe vagina/uterus. The set of curved suction tubes 124′ in the firstexample is composed of a medical-grade material that is flexible enoughto conform to intra-uterine anatomy, but rigid enough to maintain fixedangles at the point of connection between the set of curved suctiontubes 124′ and the connecting tube 126. The medical-grade material inthe example has a Shore A hardness value between 50 and 90. In theexample of the first variation, the set of curved suction tubes 124′comprises up to eight suction tubes 122′.

In the example of the first variation, each suction tube 122′ in the setof curved suction tubes 124′ comprises a lumen that is coupled, by theconnecting tube 126′, to the pump 130, and also connected to a set ofopenings 125′. A negative pressure provided by the pump 130 thereforefacilitates uterine contraction and allows intra-uterine fluids to flowthrough a set of openings 125′ into the lumen of a suction tube 122′.The set of openings 125′ in the example are oriented to open along amedial surface of a suction tube 161,162 to prevent uterine tissue orother tissue from obstructing the set of openings 125′. The set ofopenings 125′ in the example comprises openings 123′ that are between 1and 6 mm in diameter, and are also substantially smooth and rounded, asshown in the cross-section of FIG. 3D, to prevent damage to the uterusor other tissues.

In a second variation of an embodiment wherein the suction tube(s)function as a shield 127, the set of suction tubes 124″ branch from theconnecting tube 126″, and at least one of the set of suction tubes 124″comprises a set of openings 125″ along a medial surface of a suctiontube of the set of suction tubes 124″. The branched configurationfunctions to prevent tissue from obstructing the medially orientedopenings. In an example of the second variation, as shown in FIG. 4A,the set of suction tubes 124″ comprises openings 123″ that are between 1and 6 mm in diameter, and up to 16 suction tubes with smooth and/orrounded edges to prevent damage to the uterus or other tissues.

In a third variation of an embodiment wherein the suction tube(s)function as a shield 127, a suction tube 122″′ or a set of suction tubes124″′ may comprise a turnabout portion 163 configured to prevent anopening from being obstructed. In an example of the third variation, aturnabout portion 163 of a suction tube 122″′ may be configured to wraparound itself along a portion of the length of the suction tube 122″′,as shown in FIG. 4B. In another example, a set of suction tubes 124″′may comprise a suction tube 122″′ with a turnabout portion 163configured to partially wrap around a length of the set of suction tubes124″′. Alternatively, the turnabout portion 163 may not be configured topartially wrap about a suction tube 122″′, but may still provide ashield 127 by providing a barrier to prevent obstruction of an opening.

Other variations of the suction tube(s) 122, 124, shield 127, and/ordual-functioning suction tube(s) may comprise any suitable combinationof the above variations, an example of which is shown in FIG. 4C.

1.2 System—Sealing Module

The sealing module 140, which is preferably proximal to the suction end120 and comprises a deformable seal 142, functions to provide a sealsuch that negative pressure may be maintained within the uterus tofacilitate contraction of the uterus. The sealing module 140 may beconfigured to provide a seal at any point from the vulva, the cervix, orany point within the uterus, but preferably provides a seal at a pointalong the vagina distal to the uterus. The sealing module 140 may alsobe configured to be deformable, such that the sealing module 140 hasmore than one configuration; however, the sealing module 140 may beconfigured to be substantially non-deformable, such that the sealingmodule 140 only has a single configuration. Preferably, a complete seal(e.g., airtight/hermetic) is provided by the sealing module 140, suchthat a negative pressure is maintained within the uterus even after thepump 130 is deactivated; however, a non-complete seal may be provided bythe sealing module 140, such that an adequate negative pressure istransmitted to the uterus while the pump 130 is activated, but thenegative pressure is not maintained after the pump 130 is deactivated.Furthermore, at least a portion of the sealing module 140 may beconfigured to be disposable, and at least a portion of the sealingmodule 140 may be configured to be reusable.

In a first variation, the sealing module 140 is configured to provide aseal within the vaginal canal and/or at the cervix. In the firstvariation, the sealing module 140 may comprise a seal 141 that isconfigured to deform, reversibly or irreversibly, into at least twoconfigurations. A first configuration 148 preferably activates the seal,and a second configuration 149 preferably deactivates the seal.Producing the first configuration may involve an expansion (e.g.,radial, axial, uniform, non-uniform, isotropic, non-isotropic) of theseal 141, and producing the second configuration 149 may involve acontraction (e.g., radial, axial, uniform, non-uniform, isotropic,non-isotropic) of the seal 141. Producing the first configuration 148may alternatively involve releasing a constrained seal 141, andproducing the second configuration may involve constraining a releasedseal 141. However, the seal 141 in the first variation may be anon-deformable seal that has a single configuration.

In a first specific example of the first variation, as shown in FIGS. 3Aand 5A, the seal 141′ is an inflatable balloon configured to deform intoan expanded configuration 148′ and a contracted configuration 149′. Upondelivering the suction end 120 transvaginally, the seal 141′ in thefirst specific example is configured to be situated, in the contractedconfiguration 149′, within the vaginal canal. The seal 141′ may then beexpanded to produce an expanded configuration 148′ that seals the vaginain order to facilitate maintenance of a negative pressure within theuterus. In the first specific example, the seal may be expandedisotropically by delivering a fluid (e.g., saline or water) or a gas(e.g., air, nitrogen) to the interior of the inflatable balloon from asource external to the seal through an opening into the inflatableballoon. The expanded configuration 148′ of the seal in the firstspecific example substantially fills the entire cross section of theentrance of a woman's postpartum uterus (e.g., the balloon inflates tohave a volumetric capacity up to 300 milliliters, the balloon inflatesto have a volumetric capacity greater than 300 milliliters), and has adiameter between 5 and 14 cm (with a mean diameter of approximately 10cm). The inflatable balloon in the first specific example can alsowithstand an internal pressure of at least 5 psi, and can be reversed toa contracted configuration 148′ upon delivery of the fluid or gas fromthe interior of the inflatable balloon.

In the first specific example, as shown in FIGS. 5A and 5B, theinflatable balloon surrounds the connecting tube 126 coupled to thesuction end 120, such that the connecting tube 126 is isolated from andpasses entirely through the inflatable balloon. A separate deliveryconduit 143, coupleable to a fluid or gas source 144, then transfers agas or fluid through an opening into the inflatable balloon. Thedelivery conduit in the first specific example is composed of silicon,but may alternatively be composed of any other suitable material (e.g.,rubber, plastic, silicone, silastic, plastic, polyethylene,polyurethane).

In the first specific example, the seal 141 may alternatively beexpanded by producing a chemical reaction (e.g., mixture of an acid witha base, or any reaction that produces a volumetric expansion) within theinterior of the sealing balloon. For instance, an acidic solution may beisolated from a chemical base within the sealing balloon, and uponmixture of the acidic solution with the chemical base, a resultingchemical reaction may produce a controlled, volumetric expansion of thesealing balloon by the production of a gas within the sealing balloon.

In a second specific example of the first variation, the seal 141″comprises a membrane 145 and at least one deformable member 146, and isconfigured to expand radially outward into a first configuration 148″and to contract radially inward into a second configuration 149″ uponmanipulation of the deformable member 146. Upon delivering the suctionend 120 transvaginally, the seal 141″ in the second specific example isconfigured to be situated in the second configuration 149″, within thevaginal canal. As shown in FIG. 6, the deformable member 146 may beconfigured to produce an expansion in one, two, or three dimensions(e.g., upon release of a compressed elastically deformable member), andto produce a contraction in one, two, or three dimensions (e.g., uponcompression of an elastically deformable member). Alternatively, thedeformable member 146 may be a brace attached to the membrane 145 thatcan outwardly push the membrane 145 into the first configuration 148″and can inwardly pull the membrane 145 into the second configuration148″. In another alternative version of the second example, thedeformable member 146 may be a shape-memory material, such as nitinol,that outwardly pushes the membrane 145 into a first configuration 148″in one environment (e.g., within the body), and inwardly pulls themembrane 145 into a second configuration 148″ in another environment(e.g., outside of the body).

In a third specific example of the first variation, the seal 141″′ isconfigured to take on a first geometric configuration 148″′ upon anaxial deformation of the seal 141″′ and to take on a second geometricconfiguration 149″′ in response to a reverse deformation of the seal141″. Upon delivering the suction end 120 transvaginally, the seal 141″′in the third specific example is configured to be situated, in the firstgeometric configuration 149″′, within the vaginal canal. In the thirdspecific example, the seal 141″′ may be structurally configured with awall that produces a sealing configuration 148″′ upon axial deformationand to produce a non-sealing configuration 149″′ upon removal of theaxial deformation, as shown in FIG. 7. The wall may further compriseridges or other structures that control deformation into the sealingconfiguration 148″. Alternatively, the seal 141″′ may be composed of anincompressible, deformable material, such that axial deformationproduces an outward expansion to form the seal, and removal of the axialdeformation results in an inward contraction that reverses the seal. Inanother alternative version of the third example, the seal 141″′ maycomprise a shape-memory material, such as nitinol, that forms a sealingconfiguration 148″′ in one environment (e.g., within the body), andforms a non-sealing configuration 149″′ in another environment (e.g.,outside of the body).

In a fourth specific example of the first variation, the seal 141″″comprises a porous material (e.g., sponge, polymer hydrogel) that isconfigured to deform into an expanded configuration 148″″ uponabsorption of a fluid, and to be in a non-expanded configuration 149″″in the absence of a fluid. The porous material may be inserted into thebody in a non-expanded configuration 1497 and may form the expandedconfiguration 148″″ of the seal upon absorption of blood, uterinefluids, or any other fluids. The seal 141″″ of the fourth example maythus further function to control blood loss/hemorrhaging by absorbingblood.

In a second variation, the sealing module 140 is configured to provide aseal at the vulva in an extracorporeal manner. In an example of thesecond variation, the sealing module 140 comprises a membrane 146configured to seal the entrance to the vagina external to the body. Themembrane 146 has an area larger than the entrance to the vagina, suchthat an adequate seal may be formed. The sealing module 140 may furthercomprise a sealant 147 (e.g., gel or lubricant) placed between themembrane 146 and the body, such that a hermetic and airtight seal isformed at the vulva. In this manner, the entrance to the vagina issubstantially sealed to allow a negative pressure to be provided withinthe uterus.

In other variations, the sealing module 140 may only have a singleconfiguration 148 configured to produce a seal upon insertion into thebody. Prior to insertion, the vagina or vaginal canal may be manuallyexpanded (e.g., with a speculum operated by a health care provider), thesealing module 140 may be inserted (with the suction end 120 alreadyinserted), and the vagina or vaginal canal may then be released to forma seal about the sealing module 140. In an example, the sealing module140 is a substantially rigid structure that has a cross section largerthan the cross section of the vaginal canal, such that the vaginal canalseals around the rigid structure.

Additional variations of the sealing module 140 may comprise anysuitable combination of the above variations, or combination of any ofthe above variations with any other suitable sealing element.Furthermore, in other variations, as shown in FIG. 8A, the connectingtube 126 of the suction module 110 may be coupled to the sealing module140, such that a negative pressure provided by the suction module 110contracts the uterus and produces a sealing configuration by the sealingmodule 140. Additionally, other variations may comprise a sealing module140 that functions as a shield 127 (or is physically coextensive with ashield), an example of which is shown in FIG. 8B. Again, the sealingmodule may comprise any suitable combination or configuration ofelements as described.

1.3 System—Other Elements

As shown in FIG. 1, the system 100 may further comprise a pump 130,which functions to generate the negative pressure in order to contractthe uterus. The pump may comprise a clinical (e.g., hospital) suctionline, vacuum device, or any appropriate pump (e.g., syringe pump,peristaltic pump) that can produce an adequate negative pressure tocontract the uterus. In a specific example, the pump generates anegative pressure within the uterus of up to 3 psi. In one variation,the connecting tube 126 of the suction module 110 is configured tocouple to the pump 130 in a reversible manner. However, the connectingtube 126 may also terminate in a pump element in a non-reversiblemanner, such that the pump 130 is integrated with the system 100. In anexample, the pump element is a hollow chamber with a naturally expandedconfiguration. The pump element in the example may be constrained in adepressed state prior to delivering the suction end 120 into the uterus,after which the pump element is released to expand freely. Expansion ofthe pump element thus generates the negative pressure required tofacilitate contraction of the atonic uterus.

Also shown in FIG. 1, the system 100 may further comprise a filter 150,which functions to filter fluids and other substances that have enteredthe connecting tube 126. The filter is preferably distal to the pump 130and proximal to the suction end 120, such that any substance that entersthe suction end 120 is filtered prior to reaching the pump 130.Alternatively or additionally, the opening(s) of the suction end 120 maycomprise filters that function to prefilter substances that enter thesuction end 120. The filter 150 preferably comprises a membrane withpores that prevent passage of unwanted substances into the pump.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the system without departingfrom the scope of this invention.

2. Method

As shown in FIG. 9, a uterine hemorrhage controlling method 200comprises: shielding a suction module that has been delivered into auterus S210, sealing an entrance into the uterus while the suctionmodule is situated within the uterus S220; coupling the suction moduleto a pump S230; applying a negative pressure within the uterus uponactivation of the pump S240; and maintaining the negative pressurewithin the uterus to induce uterine contraction S250. The method 200 mayfurther comprise delivering the suction module into the uterus S260;transmitting bodily fluids out of the uterus through the suction moduleS270, and filtering the bodily fluids S280. The method 200 thusfunctions to reduce or entirely stop uterine hemorrhaging, in order tosubstantially reduce total blood lost from the uterus after childbirth.The method 200 may further function to reduce other issues associatedwith childbirth, including a need for a blood transfusion or ahysterectomy. Furthermore, because the method 200 is performedtransvaginally, a patient may remain conscious while the method 200 isperformed. The method 200 is preferably performed by the system 100described above or using the system 100 described above; however, themethod 200 may be performed by or using any other suitable system.

Step S210 recites shielding a suction module that has been deliveredinto a uterus, and functions to prevent obstruction of a suction moduleopening, such that a negative pressure may be applied to the interior ofthe uterus. Preferably, Step S210 is performed using any suitablevariation of the shield and/or dual-functioning suction end describedabove. For example, Step S210 may be implemented using a shield toshield the suction tube, or may be implemented using a suction tube withmedially oriented openings, such that the suction tube dually functionsas a shield. However, Step S210 may be formed using any suitable elementor method to prevent uterine tissue or any other tissue from blocking anopening of the suction module.

Step S220 recites sealing an entrance into the uterus while the suctionmodule is situated within the uterus, and functions to enablemaintenance of a negative pressure within the uterus. Preferably, StepS220 is performed using any suitable variation of the sealing moduledescribed above, an example of which is shown in FIG. 10; however, StepS220 may be formed using any suitable element or method configured toseal an entrance into the uterus. In a first example, Step S220comprises expanding an inflatable balloon seal (e.g., by deliveringfluid or gas into the balloon) at the entrance to the uterus. In thefirst example, the inflatable balloon may be inflated near the distalend of the vagina to a pressure of up to 5 psi. In a second example,S220 comprises producing a radial expansion of a membrane seal. In athird example, S220 comprises axially deforming a seal to transform theseal into a sealing configuration. In a fourth example, S220 comprisesapplying a sealant external to the vaginal canal and placing a sealingmembrane at the entrance to the vaginal canal to create a seal. In afifth example, S220 comprises manually expanding the vaginal canal,placing a sealing element into the vaginal canal, and then allowing thevaginal canal to contract about the sealing element to create the seal.Other variations of S220 may comprise other manipulations of systemvariations described above, or any other suitable method of sealing anentrance to the uterus.

Step S230 recites coupling the suction module to a pump, and functionsto prepare the suction module to transmit a negative pressure to theinterior of the uterus. Step S230 may be performed before or after thesuction module has been delivered to the interior of the uterus. In onevariation, Step S230 may comprise coupling a connecting tube of thesuction module to a clinical suction line, as shown in FIG. 12, but inother variations, Step S230 may alternatively comprise coupling anysuitable portion of a suction module to any suitable pump element.

Step S240 recites applying a negative pressure within the uterus uponactivation of the pump, and functions to generate a stimulus thatenables an atonic uterus to contract, thus counteracting uterine atony.The negative pressure may result in a uniform mechanical stimulus or anon-uniform mechanical stimulus that results in contraction of theuterus to control hemorrhaging. For instance, the negative pressure maybe a hydrostatic pressure. In an example, the pump is activated toproduce a flow rate of less than 30 liters per minute, and a negativepressure of up to 3 psi within the uterus, while monitoring pressurelevels using a pressure sensor.

Step S250 recites maintaining the negative pressure within the uterus toinduce uterine contraction, and functions to facilitate closing ofexposed uterine arterioles in the uterine wall. Step S250 may furtherfunction to decrease the possibility of the uterus returning to anatonic state. Preferably, the negative pressure is maintained untilhemorrhaging has been reduced to safe levels or has substantiallystopped. The negative pressure may also be maintained as long as deemednecessary to maintain the uterine contraction, and in a specificexample, is maintained for between 1 and 24 hours. In an example,maintenance of a negative pressure of 3 psi within the uterus causes theuterus to fully contract within 15 seconds. Additionally, Step S250 maycomprise monitoring a patient's blood pressure and heart rate while thenegative pressure is maintained, and eliminating the negative pressureafter levels have returned to a normal level. In an example, thenegative pressure may be eliminated once the patient's systolic bloodpressure is between 90 and 140 mm Hg, and the patient's heart rate isbetween 40 and 100 beats per minute. The negative pressure is preferablyeliminated once hemorrhaging has been reduced to safe levels or hassubstantially stopped. The negative pressure may be eliminated byremoval of a seal to the entrance to the uterus, which may be performedin any suitable manner (e.g., deflation of an inflatable balloon seal,radial contraction of a membrane, etc.).

As shown in FIG. 11, Step S250 may further comprise Step S255, whichrecites obstructing a connection between the suction module and thepump. Step S255 functions to maintain a negative pressure within theuterus, even upon deactivation of the pump. Step S255 also functions toprevent premature elimination of a negative pressure within the uterus(e.g., upon deactivation of the pump). Step S255 may further function toallow intrauterine tissue to re-energize, and may further function tofacilitate removal of the suction module from the uterus. In onevariation, Step S255 may comprise clamping a connecting tube between thesuction module and the pump, as shown in FIG. 11. In another variation,the connection may be a valved connection, such that Step S255 comprisesshutting a valve to obstruct a connection between the suction module andthe pump. Step S255 may, however, comprise any suitable variation ofobstructing a connection between the suction module and the pump.

As shown in FIGS. 9 and 10, the method 200 may further comprise StepS260, which recites delivering the suction module into the uterus. StepS260 functions to initiate treatment of an atonic uterus. Preferably,Step S260 comprises delivering the suction end of the suction moduledescribed above into the uterus; however, Step S260 may comprisedelivering any suitable suction module into the uterus. The reverse ofStep S260, as shown in FIG. 11, may comprise removing the suction modulefrom the uterus, and in an example, may comprise clamping a connectingtube to the suction module, deactivating the pump, and then withdrawingthe suction module from the uterus. Other variations of Step S260 andthe reverse of Step S260 may comprise any other suitable methods ofdelivering the suction module into the uterus and removing the suctionmodule from the uterus.

As shown in FIGS. 9 and 12, the method 200 may further comprise StepS270, which recites transmitting bodily fluids out of the uterus throughthe suction module. Step S270 functions to remove fluids from within theuterus in the process of inducing contraction of an atonic uterus. Thebodily fluids preferably pass into at least one opening of the suctionmodule and into the connecting tube of the suction module; however, StepS270 may alternatively comprise any other means for transmitting bodilyfluids out of the uterus.

Also shown in FIGS. 9 and 12, the method 200 may further comprise StepS270, which recites filtering the bodily fluids. Step S280 functions toprevent unwanted substances from entering the pump, which allows thepump to maintain proper function and to continually apply a negativepressure. Step S280 may further function to enable monitoring of bloodloss. For example, filtering the bodily fluids S280 into a transparentcontainer may allow a caretaker to monitor a quantity of blood lostduring implementation of the method 100. Step S280 may occur at anypoint along the suction module, distal to the pump; however, Step S280preferably occurs along a connecting tube coupled to the pump.

The FIGURES illustrate the architecture, functionality and operation ofpossible implementations of systems and methods according to preferredembodiments, example configurations, and variations thereof. In thisregard, each block in the flowchart or block diagrams may represent amodule, segment, or step, which comprises one or more executableinstructions for implementing the specified logical function(s). Itshould also be noted that, in some alternative implementations, thefunctions noted in the block can occur out of the order noted in theFIGURES. For example, two blocks shown in succession may, in fact, beexecuted substantially concurrently, or the blocks may sometimes beexecuted in the reverse order, depending upon the functionalityinvolved.

The system and method of the embodiments can be embodied and/orimplemented at least in part as a machine configured to receive acomputer-readable medium storing computer-readable instructions. Theinstructions can be executed by computer-executable componentsintegrated with an application, applet, host, server, network, website,communication service, communication interface,hardware/firmware/software elements of a user computer or mobile device,or any suitable combination thereof. Other systems and methods of theembodiments can be embodied and/or implemented at least in part as amachine configured to receive a computer-readable medium storingcomputer-readable instructions. The instructions can be executed bycomputer-executable components integrated by computer-executablecomponents integrated with apparatuses and networks of the typedescribed above. The computer-readable medium can be stored on anysuitable computer readable media such as RAMs, ROMs, flash memory,EEPROMs, optical devices (CD or DVD), hard drives, floppy drives, or anysuitable device. The computer-executable component can be a processorbut any suitable dedicated hardware device can (alternatively oradditionally) execute the instructions.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

We claim:
 1. A uterine hemorrhage controlling system comprising: aconnecting tube comprising a lumen and further comprising a proximalportion configured to connect to a pump; a suction module configured forinsertion into a uterus, the suction module comprising a flexiblesuction tube configured to form a loop, a set of openings defined alonga medial surface of the loop of the flexible suction tube, wherein theset of openings is configured to be medially oriented away from aninterior surface of the uterus when the suction module is delivered intothe uterus, and configured to fluidly connect to the lumen of theconnecting tube, and wherein activation of the pump generates a negativepressure at the set of openings to induce uterine contraction about theloop without obstruction of the set of openings; a shield coupled withthe flexible suction tube and configured to limit obstruction of the setof openings; and a seal coupled to the connecting tube between thesuction module and the pump and operable in a first configuration, theseal configured to hermetically seal an entrance to the uterus tomaintain a negative pressure within the uterus in the firstconfiguration, thereby closing exposed arterioles of the uterus in orderto control uterine hemorrhaging, wherein the seal comprises a balloonconfigured to have an expanded configuration, as the firstconfiguration, and a contracted configuration, as a secondconfiguration.
 2. The system of claim 1, wherein the shield isconfigured to flank a portion of the flexible suction tube and todiverge outward proximal to at least one opening of the set of openings.3. The system of claim 1, wherein the balloon surrounds the connectingtube at a location between the pump and the suction module, and issubstantially concentric with the connecting tube.
 4. The system ofclaim 1, wherein the expanded configuration of the balloon produces aballoon diameter substantially between 5 and 14 cm.
 5. The system ofclaim 1, wherein the balloon has a volumetric capacity of up to 300 mLand is configured to with stand an internal pressure of at least 5 psi.6. The system of claim 1, wherein an axial deformation of the sealproduces a sealing configuration that blocks an entrance to the uterus.7. The system of claim 1, wherein the balloon comprises an openingconfigured to receive at least one of a gas and a fluid that expands theballoon into the expanded configuration.
 8. The system of claim 7,wherein the opening is fluidly coupled to a delivery conduit thatdelivers at least one of a gas and a fluid into the balloon, and whereinthe delivery conduit comprises a delivery tube that runs parallel withthe connecting tube.
 9. The system of claim 1, wherein the flexiblesuction tube is configured to reversibly deform for delivery to theuterus.
 10. The system of claim 1, wherein the shield is flexible.
 11. Auterine hemorrhage controlling system comprising: a connecting tubecomprising a lumen and further comprising a proximal portion configuredto connect to a pump; a suction module configured for insertion into auterus, the suction module comprising a flexible suction tube configuredto form a loop, a set of openings defined along a medial surface of theloop of the flexible suction tube, wherein the set of openings isconfigured to be medially oriented away from an interior surface of theuterus when the suction module is delivered into the uterus, andconfigured to fluidly connect to the lumen of the connecting tube, andwherein activation of the pump generates a negative pressure at the setof openings to induce uterine contraction about the loop withoutobstruction of the set of openings; a shield coupled with the flexiblesuction tube and configured to limit obstruction of the set of openings;and a seal coupled to the connecting tube between the suction module andthe pump and operable in an expanded configuration, the seal configuredto hermetically seal an entrance to the uterus to maintain a negativepressure within the uterus in the expanded configuration, therebyclosing exposed arterioles of the uterus in order to control uterinehemorrhaging, wherein the seal comprises a balloon configured to havethe expanded configuration and a contracted configuration, the balloonincluding an opening fluidly coupled to a delivery conduit that runsparallel with the connecting tube and that delivers at least one of agas and a fluid into the balloon that expands the balloon into theexpanded configuration.
 12. The system of claim 11, wherein the balloonsubstantially surrounds the connecting tube at a location between thepump and the suction module and is substantially concentric with theconnecting tube.
 13. The system of claim 11, wherein the expandedconfiguration of the balloon produces a balloon diameter from 5 to 14cm, and wherein the balloon has a volumetric capacity of up to 300 mL tosubstantially seal the entrance to the uterus.
 14. The system of claim11, wherein the shield is configured to flank a portion of the flexiblesuction tube and to diverge outward proximal to at least one opening ofthe set of openings.
 15. The system of claim 11, wherein an axialdeformation of the seal produces a sealing configuration that blocks anentrance to the uterus.
 16. The system of claim 11, wherein the ballooncomprises an opening configured to receive at least one of a gas and afluid that expands the balloon into the expanded configuration, whereinthe opening is fluidly coupled to a delivery conduit that delivers atleast one of a gas and a fluid into the balloon, and wherein thedelivery conduit comprises a delivery tube that runs parallel with theconnecting tube.
 17. The system of claim 11, wherein the flexiblesuction tube is configured to reversibly deform for delivery to theuterus.
 18. The system of claim 11, wherein the shield is flexible.